Visual Performance With a Hydrophobic Aspheric Monofocal IOL

Cataract Clinical Trial

Official title:

Visual Performance Following Implantation of a Hydrophobic Aspheric Monofocal Intraocular Lens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03819582
• Other study ID #: 17/WM/0181
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2019
• Source: University of Plymouth
• Contact: Phillip Buckhurst
• Phone: 07825429121
• Email: phillip.buckhurst[@]plymouth.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. Monofocal Intraocular lenses are the mainstay of cataract surgery, but with advancing technologies and a wider selection of lenses available, demand for improved outcomes, improved lens design and ease of surgical implantation have increased. The purpose of this study is to assess the visual performance of the EyeCee One monofocal intraocular lens. In addition an assessment of the ease of insertion by the surgeon will be quantified.

Description:

Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. There are many different designs of monofocal IOLs, all with their own unique optical properties, however there is little evidence to support which optical design provides the best visual outcome. This research project allows us to assess the visual outcomes of a specific monofocal IOL. It also allows us to assess the ease of use of the lens to the surgeon.

Each subject will be evaluated at two visits following IOL implantation; visit 1 (1 month post implantation), Visit 2 (3 months post implantation).

At both post-operative visits the patient will undergo:

Refraction Uncorrected and best corrected distance and near visual acuity measurement Optical biometry to assess ELP Slit lamp biomicroscopy to assess for post-operative complications

At the time of surgery, the ophthalmic surgeon will complete a questionnaire, detailing lens insertion time and ease of use.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

-Clinically significant Cataract requiring cataract surgery

Exclusion Criteria:

• Amblyopia

• Corneal astigmatism of >1.00D

• Dilated pupil size smaller than 5mm

• Macular pathology

• Glaucoma

• Retinal disease

• Corneal disease

• Abnormal iris

• Pupil deformation

• Any previous corneal or intraocular surgery

• Any patient who had surgical complications will also be excluded from participation in the study.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• EyeCee One intraocular lens
Hydrophobic aspheric monofocal intraocular lens

Locations

Country	Name	City	State
United Kingdom	BMI Southend Hospital	Westcliff-on-Sea	Essex

Sponsors (1)

Lead Sponsor	Collaborator
University of Plymouth

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity early post operative	Visual acuity measured in LogMAR early post operatively	1 month post operatively
Primary	Visual acuity after 3 months post operatively	Visual acuity measured in LogMAR measured 3 months post operatively	3 months post operatively
Secondary	Ease of use to surgeons	Questionnaire completed by the surgeon to determine the usability of the intraocular lens	During surgery